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NCT03958123 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Effects of Multiple Doses of Cebranopadol on the Electrical Activity of the Heart in Healthy Subjects
A Phase 1 study, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
NCT03958123: Completed Phase 1 study, sponsored by Tris Pharma.
NCT03958123 is a Phase 1 study that has completed, run by Tris Pharma. The registered enrollment target is 171 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03958123, a Phase 1 study, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the electrical activity of the heart in healthy participants. The study consisted of a screening period within 21 days before the first dose of investigational medicinal product (IMP) (between Day -25 and Day -4) during which informed consent was obtained and the general suitability of the participants for the trial was assessed according to the inclusion/exclusion criteria. Participants were confined to the trial site from 4 days before first IMP dosing on Day 1 to 4 days after last IMP dosing on Day 30. During this period, multiple-doses of cebranopadol or matching placebo and a single-dose of moxifloxacin or matching placebo were administered. Moxifloxacin was used as a positive control. It has consistently shown that it has an effect on the heart rhythm. Continuous 12-lead ECGs were recorded at defined time points. Multiple blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory monitoring (hematology, chemistry, and urinalysis). Additional safety evaluations included recording of adverse events, vital signs (systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature, and weight), oxygen saturation, standard 12-lead ECG, Clinical Opiate Withdrawal Scale (COWS) assessment, and Columbia-Suicide Severity Rating Scale (C-SSRS) assessment. An End-of-Trial Visit was performed on Day 34, or within 7 days after the last pharmacokinetic sample on Day 34, or at early withdrawal.
Primary Outcome
Largest time-matched mean difference between cebranopadol and placebo in supported sitting QT interval corrected for heart rate using an individual correction (QTcNi) change from time-matched baseline measurement on Day -1.
Interventions
- DRUG 100 μg cebranopadol
- DRUG 200 μg cebranopadol
- DRUG 400 μg cebranopadol
- DRUG Placebo to cebranopadol encapsulated tablets
- DRUG 400 mg Moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2013-07-10 |
| Est. Completion | 2013-11-27 |
| Phase | Phase 1 |
What the finished NCT03958123 record still lists
NCT03958123 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher).
The record links to 0 conditions, and to 5 interventions - of which 100 μg cebranopadol is the first listed.
NCT03958123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03958123 about?
NCT03958123 is a clinical study titled "Evaluation of the Effects of Multiple Doses of Cebranopadol on the Electrical Activity of the Heart in Healthy Subjects". The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the electrical activity of the heart in healthy participants. The study consisted of a screening period within 21 days before the first dose of investigational medicinal product (IMP) (between Day -25 and Day -4) d...
What is the current status of trial NCT03958123?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2013-07-10. Estimated completion is 2013-11-27.
What interventions are being tested in trial NCT03958123?
The interventions under investigation include: 100 μg cebranopadol (DRUG), 200 μg cebranopadol (DRUG), 400 μg cebranopadol (DRUG), Placebo to cebranopadol encapsulated tablets (DRUG), 400 mg Moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT03958123?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03958123's enrollment target sits among peer trials
171 324th of 2000 higher than 1,676 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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